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Celldex Reports Phase 2 Study Results for Barzolvolimab
Celldex reported topline results from the company's Phase 2 study of barzolvolimab delivered subcutaneously in prurigo nodularis, a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. The primary endpoint of the study, the proportion of patients who achieve a four point or greater improvement in Worst Itch Numeric Rating Scale from baseline to Week 12, and key secondary endpoints were not met. The study did not meet primary or key secondary endpoints at Week 12 at either dose level evaluated. Percentage of patients with at least 4-point improvement in WI-NRS did not differentiate from placebo. Percentage of patients with Investigator's Global Assessment for Chronic Nodular Prurigo - Stage did not differentiate from placebo. No improvement observed with longer treatment. Barzolvolimab was well tolerated. Loading dose followed by dosing demonstrated favorable safety profile consistent with prior studies. Rapid and profound suppression of circulating tryptase, indicative of systemic mast cell depletion, was observed. The addition of the 450mg loading dose led to early, profound tryptase reduction that was sustained over the duration of the treatment period. This Phase 2 randomized, double-blind, placebo-controlled, parallel group study evaluated barzolvolimab compared to placebo in patients with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications were medically inadvisable. In total, 140 patients were randomly assigned to receive barzolvolimab 150mg after an initial loading dose of 450mg, 300mg after an initial loading dose of 450mg, or placebo during a 24-week treatment phase. Patients were then followed for an additional 16 weeks with no study treatment. The study enrolled patients at 48 centers across six countries, including the United States.
Celldex CFO Sam Martin to Retire in 2027
Celldex announced that Sam Martin, senior VP and CFO, has informed the company of his plans to retire in 2027. Martin has served as the company's CFO since 2017 and as a member of the Celldex finance team since April 2009. Celldex has initiated a search for a new CFO, and Martin will remain as the company's CFO through March of 2027.
Canaccord Analyst Says AbbVie's $10.9B Acquisition of Apogee Worth $144 per Share
Canaccord analyst Edward Nash says AbbVie's (ABBV) reported $10.9B takeover of Apogee Therapeutics (APGE) equates to roughly $144 per share. Apogee in premarket trading is up 50%, or $45.23, to $135.61. If an all-cash deal at $10.9B were to be announced and consummated, this would be a "huge win" for Apogee shareholders and for inflammation and immunology companies in general, the analyst tells investors in a research note. Canaccord sees Kymera Therapeutics (KYMR), Evommune (EVMN), Connect Biopharma (CNTB), Celldex (CLDX), and Nektar (NKTR) benefitting from a takeover of Apogee Therapeutics. The firm has a Buy rating on Apogee with a $130 price target.
Celldex Presents Positive Results for CDX-622 at EAACI Meeting in Istanbul
Celldex presented positive results from the Phase 1 healthy participant study of CDX-622 at the European Academy of Allergy and Clinical Immunology, EAACI, Annual Meeting in Istanbul, Turkiye. Data demonstrated that CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, indicative of mast cell depletion, and was well-tolerated at all dose levels. Building on Celldex's leadership in mast cell science, the data also demonstrated that neutralizing soluble stem cell factor enables the potential for meaningful mast cell inhibition and depletion without impacting other KIT-dependent functions. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma to assess the impact of dual neutralization of SCF and TSLP.
Celldex Presents Long-Term Results of Barzolvolimab Study
Celldex announced the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology, EAACI, Annual Meeting in Istanbul, Turkiye. The data presented demonstrated that barzolvolimab treatment results in "rapid, significant, and durable improvements" in angioedema in patients with chronic spontaneous urticaria refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing. The data continue to demonstrate barzolvolimab's potential to shift the goal of CSU treatment from symptom control to disease modification and further support the ongoing Phase 3 trials of barzolvolimab in CSU.
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